FDA Compliance Deadlines for E Liquid & E Cig Manufacturers (Updated)
FDA Compliance Deadlines for E Liquid & E Cig Manufacturers
July 26, 2016
Nicotine provided in a liquid nicotine container that is sold, offered for sale, manufactured for sale, distributed in commerce, or imported into the United States must be packaged in accordance with the poison prevention packaging standards issued by the Consumer Product Safety Commission. Therefore, all e-liquid products must be sold in child-resistant packaging in accordance with 16 C.F.R. § 1700.15.
August 8, 2016
A product cannot be produced in insanitary conditions or consist in whole or in part of any filthy, putrid, or decompose substance, or otherwise be contaminated by any added poisonous or added deleterious substance that may render the product injurious to health.
Prohibition on free samples
No manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of tobacco products. Allowing prospective adult buyers to smell or handle a tobacco product is not considered distribution as long as the product is not actually consumed, in whole or in part, in the retail facility, and the prospective buyer does not leave the facility with a free tobacco product.
The label and advertising cannot be false or misleading in any particular.
Modified Risk Tobacco Products (MRTP)
Modified risk tobacco products – statements such as “low,” “light,” and “mild” are prohibited after Aug. 8, 2016 unless FDA issues an order authorizing their marketing. Existing inventory may be sold off until 2017. See effective dates August 8, 2017 and September 8, 2017.
Prohibition on Sales to Minors
No retailer may sell covered tobacco products to any person younger than 18 years of age. All retailers must verify by means of photographic identification containing the date of birth that no person purchasing the product is younger than 18 years of age. This includes online sales. A retailer may not sell covered tobacco products with the assistance of any electronic or mechanical device (vending machine) except in facilities where the retailer ensures that no person younger than 18 years of age is present or permitted to enter, at any time.
June 30, 2017 (extended by FDA from December 31, 2016) NEW DATE TO BE DETERMINED
Establishment Registration and Product Listing
Any establishment engaged in the manufacture, preparation, compounding, or processing of a tobacco product must register with FDA the name, places of business, and all such establishments of that person.
Additionally, every person who registers shall, at the time of registration, file a list of all tobacco products (“product list”) which are being manufactured, prepared, compounded, or processed for commercial distribution. An owner or operator may authorize a third party agent to register and submit product listing information on its behalf.
August 8, 2017 (extended by FDA from February 8, 2017*) – NEW DATE TO BE DETERMINED
Each tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.
* Small scale manufacturers have until February 8, 2018 (extended by FDA from August 8, 2017)
Health Document Submission
Each tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary all documents developed after such date of enactment that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents, ingredients, components, and additives.
Existing MRTP inventory must stop manufacturing.
September 8, 2017 – NEW DATE TO BE DETERMINED
Existing MRTP distribution must stop.
May 10, 2018 – NEW DATE TO BE DETERMINED
Required Warning Statements on Packaging
All covered tobacco products must include the following warning statement on each product package: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” Also, all advertising must include this warning by this date.
Misbranding/Labeling provisions: net quantity, % domestic tobacco, name of product, advertising
A tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.
The label, packaging, and shipping containers of tobacco products other than cigarettes for introduction or delivery for introduction into interstate commerce in the United States shall bear the statement ‘sale only allowed in the United States’
August 8, 2018 – NEW DATE: AUGUST 8, 2022
Submission of Premarket Tobacco Product Application (PMTA)
The PMTA’s for the new products subject to regulations must be submitted by this date.
August 8, 2022
PMTA Premarket Authorization
The new products subject to regulation must obtain premarket authorization through a PMTA by this date to continue to stay on the market.
Listing and Reporting of Harmful and Potentially Harmful Constituents (HPHC)
Each manufacturer or importer, or agents thereof, shall submit to the Secretary a listing of all constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product, by brand and by quantity in each brand and subbrand.
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